Between October 25th and 27th, the FDA inspected Pacific BioLabs for GLP compliance. The FDA inspector looked at the following systems or items:

Vendor list and approval process

Internal audits

IACUC membership

Qualification of feed

Deviations

CAPAs

Cleanroom access

Training documents

SOPs

Calibration reports

Master study schedule

Change control

Archiving of GLP studies

GLP supplies

Service agreements with suppliers

GLP study packets

Temperature mapping of rooms

Temperature readings for chambers

There were no observations and no 483 written. All Pacific BioLabs' procedures and systems were found to be in compliance with GLP regulations. PBL prides itself on providing excellent service to clients and one aspect of good service is providing high quality testing that stands up to regulatory scrutiny.